A company and three of its officers settled charges brought by the federal government that they deceptively marketed a dietary supplement to women who are menopausal or perimenopausal.
In an amended complaint filed in California, FTC alleged Lunada Biomedical Inc. and the other defendants made unsubstantiated claims that its product, Amberen, was clinically proven to cause substantial and sustained weight loss in the targeted group of women. Among other allegations, the government further argued the defendants made unfounded claims that the dietary supplement was shown by clinical evidence to alleviate common symptoms of menopause, including fatigue, hot flashes, irritability, night sweats and sleep problems, according to an FTC news release.
Under a proposed stipulated order, the defendants are prohibited from making unsubstantiated efficacy or health benefit claims for any dietary supplement, food or drug, FTC said. The proposed order also bars other unlawful conduct related to consumer satisfaction claims, "risk free trial" offers and consumer endorsements, the release noted.
Amberen was supposedly developed by scientists at the Institute of Theoretical and Experimental Biophysics at the Russian Academy of Sciences, and the defendants have marketed Amberen in the United States since at least 2007, FTC said in its amended complaint.
From 2010 through 2013, Amberen generated revenues of nearly US$65 million, according to the complaint. While the defendants are subject to a $40 million judgment, all but $250,000 will be suspended due to their inability to pay, said the agency, which is responsible for cracking down on unfair or deceptive acts or practices in interstate commerce.
Lunada, and legal representatives for the company, did not immediately respond to requests for comment.
According to Amberen’s website, the supplement “targets the cause of menopause and relieves common menopausal symptoms by naturally stimulating the body to produce its own hormones again." In support of the product’s benefits, such as relief from hot flashes, irritability and stress, Lunada cites recent clinical trials involving 102 and 125 menopausal women between the ages of 42 and 60.